The invention relates to the area of medicine and may be used for the treatment of functional disorders or condition of gastrointestinal tract (GIT), including irritable bowel syndrome and disorders of the motor-evacuator function of the GIT, including the intestines.
Treatment of erosive and inflammatory diseases of the gastrointestinal tract based on ultra-low doses of histamine antibodies is known in the art (RU 2197266 C1). However, this pharmaceutical preparation cannot in all cases ensure sufficient therapeutic efficacy for treatment of functional bowel disorders.
The therapeutic effect of an extremely diluted form (or ultra-low form) of antibodies potentized by homeopathic technology (activated potentiated form) has been discovered by Dr. Oleg I. Epshtein. For example, U.S. Pat. No. 7,582,294 discloses a medicament for treating Benign Prostatic Hyperplasia or prostatitis by administration of a homeopathically activated form of antibodies to prostate specific antigen (PSA). Ultra-low doses of antibodies to gamma interferon have been shown to be useful in the treatment and prophylaxis of treating diseases of viral etiology. See U.S. Pat. No. 7,572,441, which is incorporated herein by reference in its entirety.
The S-100 protein is a cytoplasmic acidic calcium binding protein found predominantly in the gray matter of the brain, primarily in glia and Schwann cells. The protein exists in several homo- or heterodimeric isoforms consisting of two immunologically distinct subunits, alpha and beta. The S-100 protein has been suggested for use as an aid in the diagnosis and assessment of brain lesions and neurological damage due to brain injury, as in stroke. Yardan et al., Usefulness of S100B Protein in Neurological Disorders, J Pak Med Assoc Vol. 61, No. 3, March 2011, which is incorporated herein by reference.
Ultra-low doses of antibodies to S-100 protein have been shown to have anxiolytic, anti-asthenic, anti-aggressive, stress-protective, anti-hypoxic, anti-ischemic, neuroprotective and nootropic activity. See Castagne V. et al., Antibodies to S100 proteins have anxiolytic-like activity at ultra-low doses in the adult rat, J Pharm Pharmacol. 2008, 60(3):309-16; Epstein O. I., Antibodies to calcium-binding S100B protein block the conditioning of long-term sensitization in the terrestrial snail, Pharmacol Biochem Behav., 2009, 94(1):37-42; Voronina T. A. et al., Chapter 8. Antibodies to S-100 protein in anxiety-depressive disorders in experimental and clinical conditions. In “Animal models in biological psychiatry”, Ed. Kalueff A. V. N-Y, “Nova Science Publishers, Inc.”, 2006, pp. 137-152, all of which are incorporated herein by reference.
The present invention is directed to a combination pharmaceutical composition and methods of its use in treatment of functional disorders of gastrointestinal tract, including irritated bowel syndrome and disorders of the motor-evacuator function.
The solution to the existing problem is presented in form of a combination pharmaceutical composition for treatment and prophylaxis of diseases or conditions of functional etiology of the gastrointestinal tract which comprises activated-potentiated form of antibodies, to histamine activated-potentiated form of antibodies to tumor necrosis factor alpha (TNF-α) and activated-potentiated form of antibodies to brain-specific protein S-100.